NCT02444195已完成不适用
Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
- •Age 18 or greater
- •Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
- •Able to understand and read English
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patients must have working telephone, mobile or land line
排除标准
- •Severe hearing impairment that limits the ability to use audio-based guided imagery modules
- •Current documented alcohol abuse or illicit drug substance abuse
- •Planned outpatient surgery
- •Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.
结局指标
主要结局
Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
时间窗: postoperative day 1
Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.
时间窗: 6-8 week postoperative exam
次要结局
- Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).(postoperative day 1 and 6-8 week postoperative exam)
- Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.(6-8 week postoperative visit)
- The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.(postoperative day 1 and 6-8 week postoperative exam)
- Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain(postoperative day 1 and 6-8 week postoperative exam)
- Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.(postoperative day 1 and 6-8 week postoperative exam)
- Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.(postoperative day 1 and 6-8 week postoperative exam)
- Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.(postoperative day 1 and 6-8 week postoperative exam)
- Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).(postoperative day 1 and 6-8 week postoperative exam)
研究者
Brandy Michaels
Gynecologic Oncology Fellow
University of Michigan
研究点 (2)
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